Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases (CEIOUSCLM)

Factors Influencing the Impact of Contrast-Enhanced Intraoperative Ultrasound During Liver Surgery for Colorectal Cancer Liver Metastases

Contrast-enhanced intraoperative ultrasound (CE-IOUS) during surgery for colorectal liver metastases (CLM) has become a part of clinical practice. However, if it should be selectively or routinely applied remains unclear. This study is carried out to clarify which are the criteria for a selective use of CE-IOUS if any.

Study Overview

• Status: Completed
• Conditions: Colon Cancer Liver Metastasis
• Intervention / Treatment: Procedure: Contrast-enhanced intraoperative ultrasound

Detailed Description

Contrast-enhanced intraoperative ultrasound (CE-IOUS) during surgery for colorectal liver metastases (CLM) is entered in clinical practice. However, its impact seems to decrease with the improvement of preoperative imaging. Therefore, if CE-IOUS should be selectively or routinely applied remains unclear: a profile of patients who may benefit of CE-IOUS application has to be disclosed. The aim of this study is to define reliable criteria for a selective use of CE-IOUS during surgery for CLM. IOUS is performed using 3-6 MHz convex probe, and a 7.5-10 MHz micro convex probe. Staging is completed by CE-IOUS using the standard 3-6 MHz convex probe and the dedicated 1.88-3.76 MHz harmonic frequency probe. In all patients, 2.4 mL of sulphur-hexafluoride microbubbles (SonoVue®, Bracco, Milan, Italy) are injected through a peripheral vein by the anesthesiologist. Ultrasound guidance is used to drive the dissection plane as previously described. Reference standards are histology and imaging at 6 months after surgery. Univariate and multivariate analyses are performed. Statistical significance is set at P=0.05.

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Istituto Clinico Humanitas IRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutively enrolled patients with CLM who underwent surgery and during this procedure received IOUS and CE-IOUS.

Description

Inclusion Criteria:

• consecutively enrolled patients with CLM who underwent surgery and during this procedure received IOUS and CE-IOUS.
• each patient had at least 6 months of postoperative follow-up.

Exclusion Criteria:

• patients who after IOUS and CE-IOUS had explorative laparotomy only were excluded from the analysis since there was no histological confirmation of the tumor and most of them were lost to surgical follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

CEIOUS; One hundred and twenty-seven consecutive patients -77 males and 50 females, mean age of patients was 61 years (median 65 years; range 29-85 years)- underwent liver resection using intraoperative ultrasound and contrast-enhanced intraoperative ultrasound.

Procedure: Contrast-enhanced intraoperative ultrasound; After entering the abdominal cavity, liver mobilization is achieved by dissecting the round and falciform ligaments. IOUS is carried out with a standard 3-6 MHz convex probe, and a 7.5-10 MHz micro convex probe. Staging was completed by CE-IOUS using the standard 3-6 MHz convex probe and the dedicated 1.88-3.76 MHz harmonic frequency probe. In all patients, 2.4 mL of sulphur-hexafluoride microbubbles (SonoVue®, Bracco, Milan, Italy) are injected through a peripheral vein by the anesthesiologist.; Other Names: Sonovue, Sonazoid, CEIOUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
new colorectal liver metastases detected at contrast-enhanced intraoperative ultrasonography	October 2007 - March 2011 (up to 4 years)

Secondary Outcome Measures

Outcome Measure	Time Frame
new colorectal liver metastases detected at intraoperative ultrasonography	October 2007 - March 2011 (up to 4 years)
new colorectal liver metastases detected during 6-month postoperative follow-up	October 2007 - December 2011 (up to 4 years)

Collaborators and Investigators

• Sponsor: University of Milan
• Investigators: Principal Investigator: Guido Torzilli, MD, PhD, University of Milano

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: January 27, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (ESTIMATE): February 3, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 2, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: CLM
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms
• Other Study ID Numbers: CEIOUSCLM